Company ยท US
Mallinckrodt Group, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1995. Name variants (Inc, Corp, punctuation) are merged.
27510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DXT | Injector And Syringe, Angiographic | 6 |
| KPX | Changer, Radiographic Film/Cassette | 4 |
| KPR | System, X-Ray, Stationary | 3 |
| IXR | Table, Radiographic, Tilting | 2 |
| KQS | Table, Cystometric, Non-Electric And Accessories | 2 |
| FMW | Cover, Mattress (Medical Purposes) | 1 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 |
| FYA | Gown, Surgical | 1 |
| IXA | Cassette, Radiographic Film | 1 |
| IZP | Programmer, Changer, Film/Cassette, Radiographic | 1 |
| IZZ | Table, Radiographic, Non-Tilting, Powered | 1 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 1 |
| KKX | Drape, Surgical, Antimicrobial | 1 |
| LJH | System, Irrigation, Urological | 1 |
| LLZ | System, Image Processing, Radiological | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 19, 1995 | K945053 | LF CT HIG PRESSURE CATHETERS Mallinckrodt Group, Inc. | FOZ |
| Mar 8, 1995 | K945140 | URO-FLO Mallinckrodt Group, Inc. | LJH |
| Jan 4, 1995 | K943581 | HYDRADJUST IV UROLOGICAL TABLE Mallinckrodt Group, Inc. | IXR |
| Sep 7, 1994 | K943122 | SURGICAL DRAPES Mallinckrodt Group, Inc. | KKX |
| May 24, 1994 | K934664 | HYDRAGOWN Mallinckrodt Group, Inc. | FYA |
| Apr 27, 1992 | K920742 | HYDRAJUST IV UROLOGICAL TABLE Mallinckrodt Group, Inc. | IXR |
| Feb 4, 1992 | K912944 | CT 8000 DIGITAL INJECTION SYSTEM Mallinckrodt Group, Inc. | DXT |
| Nov 1, 1991 | K913264 | HYDRAVIEW 1000 DIGITAL IMAGE PROCESS/STOR DEVICE Mallinckrodt Group, Inc. | LLZ |
| May 20, 1991 | K905789 | FRANKLIN 9000 WALL STAND Mallinckrodt Group, Inc. | KPX |
| Dec 13, 1990 | K904147 | HUGH YOUNG II UROLOGICAL X-RAY SYSTEM Mallinckrodt Group, Inc. | KPR |
| Dec 13, 1990 | K904146 | NEURO VISION RADIOGRAPHIC X-RAY SYSTEM Mallinckrodt Group, Inc. | KPR |
| Dec 13, 1990 | K904145 | HYDRA VISION UROLOGICAL X-RAY SYSTEM Mallinckrodt Group, Inc. | KPR |
| Dec 13, 1990 | K904144 | PULMOVISION CHEST RADIOGRAPHY X-RAY SYSTEM Mallinckrodt Group, Inc. | IZP |
| Oct 9, 1990 | K902761 | AUTOMATIC CASSETTE LOADER Mallinckrodt Group, Inc. | KPX |
| Aug 10, 1990 | K902446 | DISPOSABLE STERILE TABLE TOP COVER FOR HYDRADJUST Mallinckrodt Group, Inc. | FMW |
| Aug 8, 1990 | K902221 | MODIFIED ANGIOGRAPHIC INJECTOR AND SYRINGE Mallinckrodt Group, Inc. | DXT |
| Apr 25, 1990 | K901323 | HYDRA VIEW IMAGING SYSTEM Mallinckrodt Group, Inc. | JAA |
| Jun 22, 1989 | K891403 | HUGH YOUNG II UROLOGICAL TABLE Mallinckrodt Group, Inc. | IZZ |
| Sep 2, 1988 | K882329 | L-F COILED EXTENSION TUBING Mallinckrodt Group, Inc. | DXT |
| Aug 16, 1988 | K883312 | L-F/KODAK FLEXIBLE GRID CASSETTE Mallinckrodt Group, Inc. | IXA |
| Oct 9, 1987 | K873687 | ANGIOMAT CT INJECTOR Mallinckrodt Group, Inc. | DXT |
| May 2, 1986 | K860204 | ANGIOMAT 6000 Mallinckrodt Group, Inc. | DXT |
| Feb 10, 1986 | K860040 | HYDRAJUST III UROLOGICAL TABLE Mallinckrodt Group, Inc. | KQS |
| Aug 17, 1978 | K781334 | DISPOSABLE SYRINGE FILL TUBE Mallinckrodt Group, Inc. | DXT |
| May 26, 1977 | K770836 | ULTIMAT L4 X L4, LIEBEL-FLARSHEIM Mallinckrodt Group, Inc. | KPX |
| Dec 16, 1976 | K760522 | TABLE, UROSURGICAL Mallinckrodt Group, Inc. | KQS |
| Aug 13, 1976 | K760279 | X-RAY FILM, CONVEY OR SYSTEM Mallinckrodt Group, Inc. | KPX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||